We have a vacancy for a Pharmaceutical Development Director.
Blueberry’s vision is to bring high value, innovative medicines to the market that make a real difference to patients’ lives. We are now growing, and looking for a part time Pharmaceutical Development Director to join our successful team. If you have the skills listed below, enjoy working in a dynamic, exciting environment, and really want to have a positive impact on patients’ lives, then we’d love to hear from you.
Pharmaceutical Development Director
This role will be 2-3 days/week with the scope and flexibility to develop into a full-time position.
Key duties will include:
- Lead pharmaceutical development projects across our early and late stage programs, in partnership with CMOs/CROs
- Build and maintain effective, positive working relationships with CMOs/CROs
- Work with the Chief Scientific Officer, senior team and external partners to build fully integrated project plans; developing manufacturing strategies and related activities to deliver new products for early clinical testing through to commercial-readiness
- Proactively manage projects to identify issues in timing, resources and funding to prevent delays in project milestones. Including providing solutions for issues and development of risk mitigation plans
- Assist the Financial Director and senior team with the forecasting and management of pharmaceutical development budgets.
- Work with regulatory leads and CROs to support pharmaceutical development planning for regulatory filings worldwide, including licensing applications
- Work with Preclinical team to develop strategies for advanced forms, using a Quality by Design approach
- Write and review documents for INDs/regulatory section submissions and represent the company as the pharmaceutical development expert before U.S. and European regulatory authorities
- Prepare, review and edit cGMP batch records, CMC Regulatory and Quality documents
- Prepare technical reports, publications and oral presentations
The knowledge, skills and abilities we are looking for:
- PhD or MS in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or related scientific discipline
- At least 5 years’ relevant experience in a pharmaceutical or biotechnology pharmaceutical development/cGMP environment
- Background in drug formulation, ideally topical, including CMC and clinical drug supply
- Proven experience in building relationships and managing collaborations with external CMOs/CROs
- A team player with strong project management skills
- Experienced with cGMP manufacturing and IND, CTA and NDA filings; thorough knowledge of relevant FDA and EMEA regulations
- Good communication skills, both written and oral
- Experience in supply chain management
- Able to identify and resolve critical issues
- Flexibility and the willingness to get involved with other activities that support the development of our drug programs
- Experience in implementing technical, strategic and operational plans
To apply for this role, please email Susie at email@example.com with your covering letter and CV.
Applications will be reviewed on an ongoing basis. Once sufficient suitable applications have been received, the recruitment window will close.
To recruitment companies: Blueberry Therapeutics will not be accepting applications or CVs via recruiters. Any unsolicited emails, phone calls or CVs will not be acknowledged.